Pressure Relief Algorithm Eval

Obstructive Sleep Apnea Clinical Trial

Official title:

A Prospective, Randomized, Crossover Study on the Effect of Pressure Relief Algorithms (PRA) on Therapy Pressure in APAP Therapy for Obstructive Sleep Apnea (OSA)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06407999
• Other study ID #: Home 0002
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: SleepRes Inc.
• Contact: Abinash Joshi, MD
• Phone: 615-893-4896
• Email: abinash.joshi[@]sleepcenterinfo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The PRA Effect on APAP Therapy Pressure Study is a randomized, controlled, crossover study in PAP-adherent participants with OSA. Pre-screening is conducted to establish potential eligibility based on regular usage of > 4 hours/night on patients who use an APAP device with a PRA mode. Participants would then be recruited as described below. For those who sign an informed consent, they will be instructed to use the device for the next 8 days with the PRA turned on for four consecutive nights and off for four consecutive nights, but in random orientation. To make sure that the device is not limited to APAP range when adjusting to respond to PRA, the upper limit will be changed to 20 cmH2O during the study. Additionally, only patients who have a current P95 of 8 cmH2O or greater will be eligible so that the maximum PRA setting of 3 cmH2O can be used.

Description:

The first phase of recruiting for the PRA Effect on APAP Therapy Pressure Study will be done during a single phone contact following an email recruitment. During this call, participants will be explained the study along with risks and benefits and evaluated for inclusion and exclusion criteria. If the participant is eligible to enter the study, they will be sent an electronic Informed Consent Form to sign. Once the form is signed and verified, the study can then start that evening, after the participant's device has been set for the study.

During both arms of the study, every aspect of operation of the APAP devices will be the same as those the patient normally uses, except for the following three things:

• APAP upper range limit will be set to 20 cmH2O

• PRA or 3 cmH2O will be either on or off

• Participants cannot use a V̇-Com™ device. Participants will randomly be assigned to start with or without PRA. Once the settings are remotely assigned to the device, the patient will sleep on these settings for four nights, ideally consecutively.

After four nights, the PRA setting will be remotely switched to the 2nd arm setting (on or off), and median and P95 pressure, Usage, AHI, and Leak averaged over those four nights will be downloaded. The participant will then use the device with the new settings for an additional four nights, hopefully also sequentially.

Following the 2nd group of four nights, median and P95 pressure, Usage, AHI, and Leak averaged over those four nights will be downloaded, the participant will be informed that their involvement in the study is complete, and the device will be remotely set back to the settings it had prior to the study. Participants will then receive the compensation credit.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Adherent use of = four hours/night over previous 2 months.

2. P95 = 8 cmH2O.

Exclusion Criteria:

1. Excessive alcohol consumption (>14 drinks/week).

2. The use of any illegal drug(s).

3. Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Expiratory Pressure Relief
EPR is a function used in CPAP intended to improve comfort by reducing delivered pressure during the expiratory phase. When EPR is not used, the patient receives true CPAP.

Locations

Country	Name	City	State
United States	Sleep Centers of Middle Tennessee	Murfreesboro	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
SleepRes Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P95/P90	P95/P90 represent pressure levels that eliminate breathing obstructions for at least 90% to 95% of the sleep period	Averaged over every night for each 4-night arm
Secondary	Leak	Leak measured by the device in excess of the required exhaust valve leak to purge CO2 from the breathing circuit.	Averaged over every night for each 4-night arm
Secondary	Usage	Elapsed therapy usage time measured each night	Averaged over every night for each 4-night arm
Secondary	AHI	Apnea/Hypopnea Index - Measurement of obstructive events averaged over the night in events per hour.	Averaged over every night for each 4-night arm